# FDA recall Z-1214-2023

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2022-12-12.

## Product

epoc Host 2  as follows:  Product               SMN   epoc Host 		10736387  epoc Host 2, Canada	10736388  epoc Host 2, China		10736389  epoc Host 2, Japan		10736390  epoc Host 2, Refurbished 10736393  epoc Host 2, Canada, Refurbished	 10736394  epoc Host 2, Japanese, Refurbished			 10736395  epoc Host 2, Chinese, Refurbished			 10736433  epoc Host 2, US (MC55X)						 11413524  epoc Host 2, ROW (MC55X)						 11413528  epoc Host 2, India (MC55X)						 11413541  epoc Host 2, China (MC55X)					 11413542  epoc Host 2, Japan (MC55X)					 11413543  epoc Host 2 (MC55X) - US - Refurbished		 11413601  "epoc Host 2 (MC55X) - ROW -Refurbished"	 11413602  epoc Host 2 (MC55X) - India - Refurbished	 11413603  epoc Host 2 (MC55X) - Japan - Refurbished	 11413604

## Reason for recall

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

## Distribution

Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam

## Key facts

- **Recall number:** Z-1214-2023
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-12
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1214-2023

## Citation

> AI Analytics. FDA recall Z-1214-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1214-2023. Source: US FDA. Licensed CC0.

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